R&D DS - Downstream Sr. Executive/Jr. Executive

Qualification: M.Sc. in Biotechnology

Department: R&D-DS

Key Responsibilities:

1. Planning & Scheduling: Prepare monthly experimentation plans, ensuring the availability of resources such as manpower, raw materials, consumables, and equipment.
2. Team Leadership: Lead a small team, ensuring optimal utilization of processes, equipment, and consumables. Provide training and guidance to team members.
3. Process Development: Lead and implement efficient upstream and recovery processes, particularly for biosimilars and biotherapeutics.
4. Experimentation & Optimization: Conduct DOE-based upstream experiments and optimize processes for therapeutic protein production, including scaling up and technology transfer.
5. ACTA & Technology Use: Utilize ACTA software in R&D to manage and optimize processes. Ensure the application of modern technologies for cost-effective biotherapeutic development

.

1. Problem-Solving & Troubleshooting: Proactively identify and resolve issues in experimentation, batch processing, and equipment operation in the PDL and Pilot Plant section.
2. Safety & Compliance: Ensure strict adherence to cGMP, GLP, and EHS protocols, maintaining compliance in all operations.
3. Employee Development: Conduct gap analysis and competency mapping for training needs. Focus on on-the-job training (OJT) for continuous development of staff skills.
4. Documentation: Prepare and maintain process development, scale-up, and technical documentation. Ensure accurate and timely record-keeping in compliance with GDP.
5. Cross-Functional Coordination: Collaborate with Engineering, QC, and other departments for effective execution of plans and implementation of new technologies, including equipment modifications and cGMP requirements.

Key Requirements:

• Experience: 6+ years in R&D or biopharma-related downstream processes with hands-on experience in upstream/fermentation/recovery.
• ACTA Expertise: Proficiency in using ACTA, especially in the R&D context, for process optimization and data management.
• Technical Knowledge: Strong understanding of QBD-guided process development, scale-up, and technology transfer for biotherapeutics.
• Leadership & Team Management: Proven ability to lead, train, and mentor a small team while managing day-to-day operations.
• Process Optimization: Experience with process optimization and technology evaluation to enhance production efficiency and product quality.
• Compliance & Safety: Knowledge and adherence to cGMP, GLP, and EHS standards, with the ability to resolve non-compliance issues.
• Problem-Solving: Analytical skills to identify and address process gaps, deviations, and inconsistencies in a timely manner.
• Documentation Skills: Strong documentation skills for preparing technical reports, SOPs, and batch records.
• Cross-Department Collaboration: Ability to work effectively with internal teams (Engineering, QC, etc.) and external vendors/partners to integrate new technologies and ensure process success.
• Process Monitoring: Ensure equipment operation, training, and process standards are maintained and continuously improved.